Study of Safety and Efficacy of an Oral Contraceptive
Overview
This is a non-comparative study. the primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of the product.
Full Title of Study: “An Open Label Study of the Contraceptive Efficacy of Norethindrone and Ethinyl Estradiol.”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Prevention
- Masking: None (Open Label)
- Study Primary Completion Date: January 2009
Interventions
- Drug: Norethindrone/ethinyl estradiol
- 1 tablet per day
Arms, Groups and Cohorts
- Experimental: Norethindrone/ethinyl estradiol
- 1 tablet per day
Clinical Trial Outcome Measures
Primary Measures
- Pearl Index, 18-35 Years, MITT Population
- Time Frame: 13 cycles (28 days each), approximately 364 days
- Pregnancy rate in women 18-35 years old, Pearl Index – number of pregnancies per 100 women-years of treatment
Secondary Measures
- Mean Number of Days of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population
- Time Frame: 12 cycles (28 days each), approximately 336 days
- Mean Median Duration (Days) of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population
- Time Frame: 12 cycles (28 days each), approximately 336 days
- Each IB episode has a unique duration, with 0, 1, 2, 3 or more episodes per cycle. To obtain “mean median duration” of episodes during a cycle, take the median duration of all episodes in each cycle. If there are no episodes in the cycle, then median duration is undefined/missing for that cycle. 1 episode – median duration = duration of that episode, 2 episodes – median duration = average of 2 durations, more than 2 episodes, calculated in usual way for median of an ordered set of numbers. Once median determined for each cycle/subject, the mean & SD of those quantities calculated.
Participating in This Clinical Trial
Inclusion Criteria
- Healthy Women – Age 18-45 – At risk for pregnancy – History of regular cycles Exclusion Criteria:
- Contraindications for use of hormonal contraception – Conditions which affect the absorption or metabolism of steroid hormones – BMI>35
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: 45 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Warner Chilcott
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Herman Ellman, Study Director, Sponsor GmbH
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